Regulatory Videos

1. The Impact Of FDA Risk On Biotech Rewards With CFO And Board Director Allan Shaw 4/16/2026

   On this week's episode of the Business of Biotech, five-time public company CFO and seven-time public company board member Allan Shaw talks about why FDA decision-making feels less predictable, and how that uncertainty is reshaping clinical trial strategy, investor behavior, and the innovation ecosystem.

2. Why Requalify? 4/14/2026

   Qualification is not a one-and-done activity in regulated environments. Learn when requalification is required and how lifecycle-based testing helps ensure equipment performance and compliance.

3. Biosimilars And Complex Medicines For All With RNA Therapeutics' Sarfaraz Niazi, Ph.D. 4/9/2026

   On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes.

4. Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka 3/24/2026

   On episode 125 of Cell & Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group's Monika Swietlicka to discuss how the FDA is increasing flexibility in cell and gene therapy development without lowering evidentiary standards, emphasizing a risk-based, holistic approach.

5. Unlocking The Therapeutic Power Of Fibroblasts With Pete O'Heeron And Hamid Khoja, Ph.D. 2/24/2026

   In this episode of “Better Biopharma,” host Tyler Menichiello is joined by FibroBiologics’ CEO and Founder, Pete O’Heeron, and chief scientific officer, Hamid Khoja, Ph.D.

6. Inside a Breakthrough HER2 Immunotherapy for PMO with OS Therapies' Paul Romness 2/10/2026

   In episode 122 of Cell & Gene: The Podcast, Host Erin Harris talks to Paul Romness, CEO of OS Therapies, to learn the company’s mission to address the severe unmet need in pulmonary metastatic osteosarcoma (PMO), a rare pediatric cancer with no established standard of care once it metastasizes.

7. Bringing Curative Cell Therapies To Market with Kite Pharma's Cindy Perettie 2/6/2026

   On this week's episode of the Business of Biotech, we're speaking with Cindy Perettie, Executive Vice President and Global Head at Kite Pharma, a Gilead-owned company focused on curing cancer with cell therapies.

8. Putting Pressure On CDMOs With Herman Bozenhardt 1/27/2026

   In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance.

9. Data Governance And Regulations For AI Use In GMP With Peter Baker 1/13/2026

   In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Peter Baker, former FDA investigator and president of Live Oak Quality Assurance.

10. The Editors' Roundtable: A 2025 Retrospective of the Life Sciences Industry 1/8/2026

    We’re sharing this episode on Cell & Gene: The Podcast because Better Biopharma is a sister podcast within the Life Science Connect family. This conversation speaks directly to the challenges and opportunities our Cell & Gene: The Podcast audience is navigating right now.